PDA Letter Article

Hear From Industry, FDA Leaders on the Issues of the Day

by Susan Schniepp, Regulatory Compliance Associates, and Steven Mendivil, Amgen

Advanced biomedical innovations are leading to safer and more effective therapies for patients. At the same time, global strategies are necessary to ensure the quality of these cutting-edge medical products.

With change in the air, where can you hear what company executives are doing to supply quality, innovative products for the global marketplace? And what do regulators and industry thought leaders think of the future of pharma?

This year’s PDA/FDA Joint Regulatory Conference offers answers to these questions within the theme, “Ensuring Product Quality in an Era of Innovative Therapies.” Some of the plenary sessions have been transformed into panel discussions. Here, thought leaders from the US FDA and industry are poised to discuss future trends for the industry and the importance of innovative therapies as the industry moves forward. Other plenary sessions will feature company executives sharing their expertise about the challenges executive management faces and how their decisions impact quality. Concurrent sessions will fall under the following three tracks: “Product Quality,” “Lifecycle,” and “Innovation.” “Product Quality” includes sessions focusing on data integrity and quality metrics. “Lifecycle” sessions will look at quality systems, change and risk management, lifecycle management, and global harmonization trends. And the “Innovation” track will tackle such subjects as the importance of expedited pathways and advanced therapies, and will include a discussion of the current regulatory findings taken directly from the most current Form 483 citations.


Last, but not least, a variety of breakfast sessions will entice even night owls to get up early. These sessions will cover SOPs, investigations, good documentation practices, practical guidance for conducting smoke studies and media fills, API quality requirements for sterile drug manufacturing, and laboratory controls.

As you can see, there will be a topic of interest for everyone, from recent graduates to seasoned experts. So be sure to mark your calendar and join us this September!

Learn more about the 2017 PDA/FDA Joint Regulatory Conference and related PDA Education courses!

2017 PDA FDA